1. Field of the Invention
The subject disclosure relates to methods and systems for monitoring research trials via a distributed computing network, and more particularly to improved methods and systems for centrally monitoring research trials using statistical methods to verify the quality of the trials. Multi-center clinical trials of new therapies will be used throughout the disclosure as a typical, but by no means exclusive, example of such trials.
2. Background of the Related Art
Over the decade of 2001-2010, clinical research costs have sky-rocketed while new drug approvals have decreased by one third. At the current pace of increase in costs, adequately sized clinical trials may become infeasible. Alternatively, such costs will have to be reflected in the price of new drugs, which will eventually cause an intolerable burden on health care systems.
In view of typical trial costs, different options have been suggested to reduce some of these costs without compromising the scientific validity of the trials. The greatest potential savings lie in the labor-intensive activities such as on-site monitoring, which can represent as much as 30% of the total budget in large global clinical trials. It is therefore not surprising that the current practice of performing intensive on-site monitoring is coming into question. A draft guidance of the U.S. Food and Drug Administration (FDA) states unequivocally: “FDA encourages greater reliance on centralized monitoring practices than has been the case historically, with correspondingly less emphasis on on-site monitoring”.